Sponsored by Cerexa, Inc.

Phase	Quota	Distance
Phase 4		Near

The purpose of this study is to determine whether ceftaroline is effective and safe for the treatment of patients with Community-acquired Bacterial Pneumonia (CABP) at risk for infection due to Methicillin-resistant Staphylococcus aureus (MRSA).

Study Start Date: October 2012

Estimated Completion Date: December 2013

Specialties: Internal Medicine: Clinical Pharmacology,Infectious Disease,Pulmonology Infectious Disease: Antimicrobials,Pulm/Thoracic Infections Pulmonology: Clinical Pharmacology,Pulm/Thoracic Infections Pharmacy: Antimicrobials,Drug Trials Physician Assistant: Clinical Pharmacology,General Medicine,Infectious Disease

Interventions

• Drug: Ceftaroline fosamil
• Drug: Ceftriaxone plus vancomycin

Inclusion criteria

Subjects are required to meet ALL of the following inclusion criteria:

 

• Male or female, ≥ 18 years old
• Presence of CABP requiring hospitalization
• Presence of CABP meeting the following criteria:
• confirmed pneumonia (new or progressive pulmonary)
• Acute illness (≤ 7 days' duration) with at least 3 clinical signs or symptoms consistent with a lower respiratory tract infection
• MRSA Risk Factors
• MRSA-positive blood culture or respiratory specimen or a risk factor for MRSA such as a history of colonization with MRSA

Exclusion criteria

Subjects must NOT meet any of the following exclusion criteria at baseline:

History of any hypersensitivity or allergic reaction to any β-lactam antimicrobial

• Suspected or microbiologically-documented infection with a pathogen known to be resistant to any of the study drugs
• Non-infectious causes of pulmonary infiltrates (eg, pulmonary embolism, chemical pneumonitis from aspiration, hypersensitivity pneumonia, congestive heart failure)
• More than 24 hours of potentially effective systemic antibacterial therapy for CABP within 96 hours before randomization
• End-stage renal disease (CrCl < 15), including hemodialysis
• Evidence of significant hepatic, hematological, or immunocompromising condition

Study Locations And Contact Information

• Investigational Site, Columbus Ohio
  
• Investigational Site, Alicante
  
• Investigational Site, Lima Ohio
  
• Investigational Site, St. Petersburg
  
• Investigational Site, Moscow
  
• Investigational Site, Lublin
  
• Investigational Site, Kharkiv
  
• Investigational Site, St. Petersburg
  
• Investigational Site, Royal Oak Michigan
  
• Investigational Site, Dnipropetrovsk
  
• Investigational Site, Matrahaza
  
• Investigational Site, Lodz
  
• Investigational Site, Kharkiv
  
• Investigational Site, Iasi
  
• Investigational Site, DeLand Florida
  
• Investigational Site, Barcelona
  
• Investigational Site, Laconia New Hampshire
  
• Investigational Site, Chicago Illinois
  
• Investigational Site, Laconia New Hampshire
  
• Investigational Site, Columbus Ohio
  
• Investigational Site, Ivano-Frankivsik
  
• Investigational Site, St. Louis Missouri
  
• Investigational Site, Sylmar California
  
• Investigational Site, Barcelona
  
• Investigational Site, Tbilisi
  
• Investigational Site, Moscow
  
• Investigational Site, Kansas City Kansas
  
• Investigational Site, Lublin
  
• Investigational Site, Zaporizhzhya
  
• Investigational Site, Oklahoma City Oklahoma
  
• Investigational Site, Ivano-Frankivsik
  
• Investigational Site, Phoenix Arizona
  
• Investigational Site, Craiova Dolj
  
• Investigational Site, Tbilisi
  
• Investigational Site, Minneapolis Minnesota
  
• Investigational Site, Wilkowice-Bystra
  
• Investigational Site, Kyiv
  
• Investigational Site, Yaroslavl
  
• Investigational Site, Omaha Nebraska
  
• Investigational Site, Craiova Dolj
  
• Investigational Site, Dnipropetrovsk
  
• Investigational Site, Bucharest
  
• Investigational Site, Omaha Nebraska
  
• Investigational Site, Lima Ohio
  
• Investigational Site, Alicante
  
• Investigational Site, Lodz
  
• Investigational Site, Iasi
  
• Investigational Site, Phoenix Arizona
  
• Investigational Site, DeLand Florida
  
• Investigational Site, Matrahaza
  
• Investigational Site, Bucharest
  
• Investigational Site, Wilkowice-Bystra
  
• Investigational Site, Zaporizhzhya
  
• Investigational Site, Kyiv
  
• Investigational Site, Yaroslavl